Warning: "continue" targeting switch is equivalent to "break". Did you mean to use "continue 2"? in /var/www/tarius.com/public_html/wp-content/plugins/revslider/includes/operations.class.php on line 2734

Warning: "continue" targeting switch is equivalent to "break". Did you mean to use "continue 2"? in /var/www/tarius.com/public_html/wp-content/plugins/revslider/includes/operations.class.php on line 2738

Warning: "continue" targeting switch is equivalent to "break". Did you mean to use "continue 2"? in /var/www/tarius.com/public_html/wp-content/plugins/revslider/includes/output.class.php on line 3679
Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee – TARIUS – GLOBAL REGULATORY REQUIREMENTS
Loading Events

« All Events

Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

October 8

The committees will discuss new drug application (NDA) 211179, for amphetamine sulfate immediate-release oral capsules, submitted by Arbor Pharmaceuticals, LLC, for the proposed indication of treatment of attention deficit hyperactivity disorder. The product has been formulated with properties intended to deter non-oral abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss the overall risk-benefit profile of the product, including the potential public health impact, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.

Details

Date:
October 8
Event Category: